CompletedNCT00799058Updated Oct 25, 2022Results posted

A Safety Study of Two Dapivirine (TMC120) Vaginal Gels in the United States

A Phase 1/2 interventional study of dapivirine 4789 and dapivirine gel 4759 in HIV-1 Infections, sponsored by International Partnership for Microbicides, Inc.. Completed at 5 sites in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-25.

Sponsored by International Partnership for Microbicides, Inc. · Phase 1/2, Interventional, and Prevention

Phase: Phase 1/2
Study type: Interventional
Enrollment: 128
Allocation: Randomized
Ages: 18 Years to 40 Years
Sex: Female

Study summary

A double-blind, randomized, placebo-controlled Phase I/II trial to evaluate the safety of dapivirine Gel 4759, 0.05% 2.5 g and dapivirine Gel 4789, 0.05% 2.5 g formulations as compared to the vaginal HEC-based Universal placebo gel, 2.5 g in healthy HIV-negative women

Read the detailed description

This was a double-blind, randomized, placebo-controlled trial, to be conducted over 10 months at five research centers in the USA among 180 healthy, sexually active women, to assess the safety and acceptability of dapivirine Gel 4759, 0.05% 2.5 g, and dapivirine Gel 4789, 0.05% 2.5 g, both vaginal microbicides containing dapivirine, compared to the vaginal HEC-based Universal placebo gel, 2.5 g, containing no active ingredient, used once daily for a period of 12 weeks.

Conditions studied

HIV-1 Infections

Browse trials for

Infections 6,688

Keywords

HIV-1 infections

Who can participate

Ages eligible: 18 Years to 40 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

Inclusion criteria

Women 18 to 40 years of age inclusive who can give written informed consent
Available for all visits and consent to follow all procedures scheduled for the trial
Healthy and self-reported sexually active
HIV-negative as determined by an HIV test at time of enrollment
Willing to be on a stable form of contraception
In the absence of the use of exogenous hormone(s), have a self-reported regular menstrual cycle
Upon pelvic/speculum examination and colposcopy at the enrollment visit, the cervix and vagina appear normal as determined by qualified research center staff
Asymptomatic for genital infections at the time of enrollment
Willing to refrain from use of vaginal products or objects for 14 days prior to enrollment and for the duration of the trial.
Documentation of no abnormality on Pap smear within 90 days prior to randomization;
Willing to answer acceptability and adherence questionnaires throughout the trial
Willing to refrain from participation in any other research trial for the duration of this trial
Willing to provide adequate locator information for trial retention purposes and be reachable per local standard procedures
Willing to abstain from all the following criteria beginning 48 hours prior to each trial visit:
- Vaginal intercourse
- Oral contact with her genitalia
- Internal vaginal washing
- Penetration of the vagina by fingers, sex toys, or any other objects, including medications
Willing to abstain from all of the following for 3 days after biopsy procedures:
- Vaginal intercourse
- Oral contact with her genitalia
- Internal vaginal washing
- Penetration of the vagina by fingers, sex toys, or any other objects, including medications

Exclusion criteria

Exclusion Criteria:

Currently pregnant or having had their last pregnancy outcome within 3 months prior to screening
Currently breast-feeding, or having breastfed within 3 months prior to screening
Receipt of any investigational agent within 60 days prior to screening
Previously participated in any HIV vaccine trial
Untreated urogenital infections within 2 weeks prior to enrollment
Presence of any abnormal physical finding on the vulva, vaginal walls or cervix during pelvic/speculum examination and/or colposcopy
History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, or urethral obstruction
Pap smear result at screening that requires cryotherapy, biopsy or treatment (other than for infection)
History of symptomatic or asymptomatic HSV-2
Any Grade 2, 3 or 4 hematology, chemistry or urinalysis laboratory abnormality at baseline
Unexplained, undiagnosed abnormal bleeding per vagina during or following vaginal intercourse; or urogenital surgery within 90 days prior to enrollment
Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of sensitivity/allergy to latex
Any serious acute, chronic or progressive disease
Any condition(s) that, in the opinion of the Investigator, might interfere with adherence to trial requirements or evaluation of the trial objectives

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 128 participants (actual)

Study arms

Active comparator
dapivirine gel 4789
will be applied by participants once daily for 12-weeks treatment period
Drug: dapivirine 4789
Active comparator
dapivirine gel 4759
Will be applied by participants once daily for12-weeks treatment period
Drug: dapivirine gel 4759
Placebo comparator
HEC-based placebo gel, 2.5g containing no Dapivirine
Will be applied once daily for 12-weeks treatment period
Drug: Drug placebo

Interventions

Drugdapivirine 4789
dapivirine gel 4789, 0.05%, 2.5g applied once daily
Also known as: TMC120
Drugdapivirine gel 4759
dapivirine gel 4759, 0.05%, 2.5g applied once daily
Also known as: TMC120
DrugDrug placebo
HEC-based universal placebo gel, 2.5g applied once daily
Also known as: HEC-based placebo gel, 2.5g

What researchers measure

Primary outcomes

The Percentage of Women With the Composite Endpoint of Abnormal Safety Findings.
A composite endpoint was defined as the percentage of participants with any post-baseline abnormal finding from pelvic/speculum examination, colposcopy finding, STI diagnoses, laboratory test of DAIDS grade 3 or higher and any product-related AE. DAIDS severity grades are defined as follows: Grade 1 = mild Grade 2 = moderate Grade 3 = severe Grade 4 = potentially life-threatening Grade 5 = death
Time frame: 12 weeks

Secondary outcomes

Changes in the Vaginal Flora
Cervicovaginal fluid specimens will be obtained to determine vaginal flora before first gel application and at Visits 3, 5, and 6. Appropriate statistical analyses incorporating repeated measures will be used to assess the changes in the vaginal flora in women using Dapivirine Gel 4759, 0.05% 2.5g, Dapivirine Gel 4789, 0.05% 2.5g or the vaginal HEC-based universal placebo gel, 2.5g. Nugent scores were used to assess changes in vaginal flora, and were categorized into three levels: (1) negative for BV (score: 0-3); (2) altered vaginal flora (score: 4-6); and (3) BV (score: 7-10).
Time frame: 16 weeks
The Distribution of Dapivirine Levels Observed in Plasma Samples at Each Specified Time Point
Dapivirine levels observed in plasma will be summarized using simple descriptive statistics.
Time frame: 12 weeks
The Adherence to Once Daily Application of a Vaginal Microbicide Gel Over a 12-week Period in Healthy, Sexually Active, HIV-negative Women
Adherence is defined as the percentage of participants who used the gel each day of the preceding 14 days, based on participant self reports.
Time frame: 12 weeks
Changes in the Vaginal pH
Cervicovaginal fluid specimens will be obtained to determine vaginal pH before first gel application and at screening, enrolment and visit 5 (week 12). Appropriate statistical analyses incorporating repeated measures will be used to assess the changes in the vaginal pH in women using Dapivirine Gel 4759, 0.05% 2.5g, Dapivirine Gel 4789, 0.05% 2.5g or the vaginal HEC-based universal placebo gel, 2.5g.
Time frame: 12 weeks
The Distribution of Dapivirine Levels Observed in Vaginal Fluid at Each Specified Time Point.
The distribution of dapivirine levels observed in each type of sample will be summarized using simple descriptive statistics. In addition, the proportion of women with detectable dapivirine concentrations will be calculated for each type of sample at each collection time point. Exploratory analyses of dapivirine concentration data will also be performed to take into account information reported in a diary regarding menses and tampon use throughout the trial.
Time frame: 12 weeks. Measured at 2, 4, and 8 weeks post-enrolment and at one of these at week 12; 24, 48, or 72 hours after gel discontinuation. (Participants were randomized to have vaginal fluid samples collected at one of these visits (5a, 5b, or 5c).
The Distribution of Dapivirine Levels Observed in Vaginal Tissue at Each Specified Time Point.
The distribution of dapivirine levels observed in vaginal tissue sample will be summarized using simple descriptive statistics.
Time frame: 12 weeks. Measured at 2, 4, and 8 weeks post-enrolment and at one of these at week 12; 24, 48, or 72 hours after gel discontinuation. (Participants were randomized to have vaginal fluid samples collected at one of these visits (5a, 5b, or 5c).
Acceptability of Once Daily Application of a Vaginal Microbicide Gel Over a 12-week Period in Healthy, Sexually Active, HIV-negative Women
Acceptability was assessed as the percentage of participants at week 12 who were willing to use the gel every day if proven to prevent HIV.
Time frame: 12 weeks

Results

Posted Oct 25, 2022

Limitations and caveats

Concluding a general trend in vaginal fluid data is, however, difficult as overall individual fluid levels for the two gel formulations were in the same range and differences based on median values were not consistent across visits.

Participant flow

Approximately 180 women (35-50 per RC) were scheduled to be enrolled at 5 research centers in the USA. However, following IPM's decision to give priority to development of the dapivirine vaginal ring above that of dapivirine vaginal gel, the Sponsor decided to stop enrollment into IPM 020 trial after 128 participants were randomized. It was determined that the number of participants already enrolled were sufficient to allow for meaningful analysis of the data. Total trial duration was 18 months.

Participant flow — Overall Study
Milestone	Dapivirine Gel 4789	Dapivirine Gel 4759	HEC-based Placebo Gel, 2.5g Containing no Dapivirine
Started	43	43	42
Completed	33	34	36
Not completed	10	9	6
Withdrew: Withdrawal by subject	2	2	2
Withdrew: Lost to follow-up	1	2	1
Withdrew: Adverse event	0	2	0
Withdrew: Pregnancy	1	0	0
Withdrew: Not adherent	3	2	1
Withdrew: Discontinued use of ip due to ae, but completed visits	0	0	1
Withdrew: Ip dispensing error	1	0	0
Withdrew: Not enough ip to complete trial due to ip dispending error	0	1	0
Withdrew: Ip discontinued too long during bv treatment	1	0	0
Withdrew: Lost 2 ip kits and did not have enough remaining to complete trial	0	0	1
Withdrew: Participant did not attend clinic visit 6 (final visit)	1	0	0

Outcome measures

PrimaryThe Percentage of Women With the Composite Endpoint of Abnormal Safety Findings.

A composite endpoint was defined as the percentage of participants with any post-baseline abnormal finding from pelvic/speculum examination, colposcopy finding, STI diagnoses, laboratory test of DAIDS grade 3 or higher and any product-related AE. DAIDS severity grades are defined as follows: Grade 1 = mild Grade 2 = moderate Grade 3 = severe Grade 4 = potentially life-threatening Grade 5 = death

Time frame:: 12 weeks
Reported as:: Count of participants · Participants

The Percentage of Women With the Composite Endpoint of Abnormal Safety Findings.
Participants	Dapivirine Gel 4759	Dapivirine Gel 4789	HEC-based Placebo Gel, 2.5g Containing no Dapivirine
The Percentage of Women With the Composite Endpoint of Abnormal Safety Findings.	23	28	28

SecondaryChanges in the Vaginal Flora

Cervicovaginal fluid specimens will be obtained to determine vaginal flora before first gel application and at Visits 3, 5, and 6. Appropriate statistical analyses incorporating repeated measures will be used to assess the changes in the vaginal flora in women using Dapivirine Gel 4759, 0.05% 2.5g, Dapivirine Gel 4789, 0.05% 2.5g or the vaginal HEC-based universal placebo gel, 2.5g. Nugent scores were used to assess changes in vaginal flora, and were categorized into three levels: (1) negative for BV (score: 0-3); (2) altered vaginal flora (score: 4-6); and (3) BV (score: 7-10).

Time frame:: 16 weeks
Reported as:: Number · percentage of participants with data

Changes in the Vaginal Flora
percentage of participants with data	Dapivirine Gel 4759	Dapivirine Gel 4789	HEC-based Placebo Gel, 2.5g Containing no Dapivirine
Week 0 : Normal Flora (0-3)	66.7	60.5	54.8
Week 0 : Altered Flora (4-6)	14.3	11.6	23.8
Week 0 : Abnormal Flora (7 or more)	19.0	27.9	21.4
Week 4 : Normal Flora (0-3)	67.6	55.0	65.9
Week 4 : Altered Flora (4-6)	8.1	12.5	19.5
Week 4 : Abnormal Flora (7 or more)	24.3	32.5	14.6
Week 12: Normal Flora (0-3)	61.8	65.7	59.5
Week 12: Altered Flora (4-6)	23.5	20.0	24.3
Week 12: Abnormal Flora (7 or more)	14.7	14.3	16.2
Week 16 (Follow-up after IP discontinuation): Normal Flora (0-3)	70.6	66.7	64.9
Week 16 (Follow-up after IP discontinuation): Altered Flora (4-6)	2.9	18.2	18.9
Week 16 (Follow-up after IP discontinuation): Abnormal Flora (7 or more)	26.5	15.2	16.2

SecondaryThe Distribution of Dapivirine Levels Observed in Plasma Samples at Each Specified Time Point

Dapivirine levels observed in plasma will be summarized using simple descriptive statistics.

Time frame:: 12 weeks
Reported as:: Mean · picograms/mililiter

The Distribution of Dapivirine Levels Observed in Plasma Samples at Each Specified Time Point
picograms/mililiter	Dapivirine Gel 4759	Dapivirine Gel 4789
Week 2	536.8 ± 297.2	475.8 ± 272.2
Week 4	599.5 ± 423.1	446.1 ± 272.2
Week 8	572.6 ± 377.5	432.6 ± 276.8
Week 12	519.1 ± 351.3	366.1 ± 329.6

SecondaryThe Adherence to Once Daily Application of a Vaginal Microbicide Gel Over a 12-week Period in Healthy, Sexually Active, HIV-negative Women

Adherence is defined as the percentage of participants who used the gel each day of the preceding 14 days, based on participant self reports.

Time frame:: 12 weeks
Reported as:: Number · percentage of participants with data

The Adherence to Once Daily Application of a Vaginal Microbicide Gel Over a 12-week Period in Healthy, Sexually Active, HIV-negative Women
percentage of participants with data	Dapivirine Gel 4759	Dapivirine Gel 4789	HEC-based Placebo Gel, 2.5g Containing no Dapivirine
The Adherence to Once Daily Application of a Vaginal Microbicide Gel Over a 12-week Period in Healthy, Sexually Active, HIV-negative Women	74	73	71

SecondaryChanges in the Vaginal pH

Cervicovaginal fluid specimens will be obtained to determine vaginal pH before first gel application and at screening, enrolment and visit 5 (week 12). Appropriate statistical analyses incorporating repeated measures will be used to assess the changes in the vaginal pH in women using Dapivirine Gel 4759, 0.05% 2.5g, Dapivirine Gel 4789, 0.05% 2.5g or the vaginal HEC-based universal placebo gel, 2.5g.

Time frame:: 12 weeks
Reported as:: Mean · Vaginal pH

Changes in the Vaginal pH
Vaginal pH	Dapivirine Gel 4759	Dapivirine Gel 4789	HEC-based Placebo Gel, 2.5g Containing no Dapivirine
Screening (Week 0)	4.46 ± 0.53	4.55 ± 0.63	4.55 ± 0.95
Visit 1 (Enrollment)	4.45 ± 0.52	4.48 ± 0.5	4.3 ± 0.43
Visit 5 (Week 12)	4.4 ± 0.46	4.44 ± 0.61	4.38 ± 0.47

SecondaryThe Distribution of Dapivirine Levels Observed in Vaginal Fluid at Each Specified Time Point.

The distribution of dapivirine levels observed in each type of sample will be summarized using simple descriptive statistics. In addition, the proportion of women with detectable dapivirine concentrations will be calculated for each type of sample at each collection time point. Exploratory analyses of dapivirine concentration data will also be performed to take into account information reported in a diary regarding menses and tampon use throughout the trial.

Time frame:: 12 weeks. Measured at 2, 4, and 8 weeks post-enrolment and at one of these at week 12; 24, 48, or 72 hours after gel discontinuation. (Participants were randomized to have vaginal fluid samples collected at one of these visits (5a, 5b, or 5c).
Reported as:: Mean · nanogram/milliliter

The Distribution of Dapivirine Levels Observed in Vaginal Fluid at Each Specified Time Point.
nanogram/milliliter	Dapivirine Gel 4759	Dapivirine Gel 4789
Visit 2 (2 weeks post-enrollment)	467.1 ± 579.8	880.7 ± 1924
Visit 3 (4 weeks post-enrolment)	347.8 ± 351.9	462.6 ± 590.0
Visit 4 (8 weeks post-enrolment)	526.9 ± 580.1	298.1 ± 151
Visit 5a (24 hours after gel discontinuation)	192.0 ± 186.7	680.0 ± 1775
Visit 5b (48 hours after gel discontinuation)	98.63 ± 180.3	164.0 ± 233.1
Visit 5c (72 hours after gel discontinuation)	177.0 ± 304.9	245.6 ± 230.7

SecondaryThe Distribution of Dapivirine Levels Observed in Vaginal Tissue at Each Specified Time Point.

The distribution of dapivirine levels observed in vaginal tissue sample will be summarized using simple descriptive statistics.

Time frame:: 12 weeks. Measured at 2, 4, and 8 weeks post-enrolment and at one of these at week 12; 24, 48, or 72 hours after gel discontinuation. (Participants were randomized to have vaginal fluid samples collected at one of these visits (5a, 5b, or 5c).
Reported as:: Mean · nanogram/gram

The Distribution of Dapivirine Levels Observed in Vaginal Tissue at Each Specified Time Point.
nanogram/gram	Dapivirine Gel 4759	Dapivirine Gel 4789
Visit 5a (24 hours after gel discontinuation)	3518 ± 3579	9343 ± 18980
Visit 5b (48 hours after gel discontinuation)	841.0 ± 1582	1150 ± 1184
Visit 5c (72 hours after gel discontinuation)	4781 ± 9161	1142 ± 1337

SecondaryAcceptability of Once Daily Application of a Vaginal Microbicide Gel Over a 12-week Period in Healthy, Sexually Active, HIV-negative Women

Acceptability was assessed as the percentage of participants at week 12 who were willing to use the gel every day if proven to prevent HIV.

Time frame:: 12 weeks
Reported as:: Count of participants · Participants

Acceptability of Once Daily Application of a Vaginal Microbicide Gel Over a 12-week Period in Healthy, Sexually Active, HIV-negative Women
Participants	Dapivirine Gel 4789	Dapivirine Gel 4759	HEC-based Placebo Gel, 2.5g Containing no Dapivirine
Acceptability of Once Daily Application of a Vaginal Microbicide Gel Over a 12-week Period in Healthy, Sexually Active, HIV-negative Women	24	25	29

Adverse events

Collected over Trial duration: 18 months The maximum period of gel exposure in all three treatment groups was 12 weeks.. Non-serious events are listed at a 4% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Dapivirine Gel 4759	0/43 (0%)	1/43 (2.3%)	30/43 (69.8%)
Dapivirine Gel 4789	0/43 (0%)	0/43 (0%)	34/43 (79.1%)
HEC-based Placebo Gel, 2.5g Containing no Dapivirine	0/42 (0%)	2/42 (4.8%)	35/42 (83.3%)

Most frequent serious events

Most frequent serious events
Event	Dapivirine Gel 4759	Dapivirine Gel 4789	HEC-based Placebo Gel, 2.5g Containing no Dapivirine
Abdominal PainGastrointestinal disorders	0/43	0/43	1/42
AsthmaRespiratory, thoracic and mediastinal disorders	0/43	0/43	1/42
Cellulitis of the left breastReproductive system and breast disorders	1/43	0/43	0/42

Most frequent other events

Showing 10 of 29

Most frequent other events
Event	Dapivirine Gel 4759	Dapivirine Gel 4789	HEC-based Placebo Gel, 2.5g Containing no Dapivirine
Vaginitis bacterialInfections and infestations	7/43	15/43	5/42
DiarrhoeaGastrointestinal disorders	0/43	0/43	4/42
MetrorrhagiaReproductive system and breast disorders	1/43	3/43	4/42
Vaginal candidiasisInfections and infestations	4/43	3/43	0/42
Vulvovaginal pruritusReproductive system and breast disorders	0/43	4/43	2/42
Upper respiratory tract infectionInfections and infestations	1/43	0/43	3/42
HeadacheNervous system disorders	2/43	3/43	3/42
DysuriaRenal and urinary disorders	0/43	0/43	3/42
Vaginal dischargeReproductive system and breast disorders	0/43	1/43	3/42
SinusitisInfections and infestations	1/43	3/43	0/42

Baseline characteristics

Healthy, sexually active, HIV-negative women

Age, Continuous
Age, Continuous(years)	Dapivirine Gel 4759	Dapivirine Gel 4789	HEC-based Placebo Gel, 2.5g Containing no Dapivirine	Total
Mean	27.6 ± 5.9	27.5 ± 5.5	27.5 ± 5.5	27.6 ± 5.9

Sex: Female, Male
Sex: Female, Male(Participants)	Dapivirine Gel 4759	Dapivirine Gel 4789	HEC-based Placebo Gel, 2.5g Containing no Dapivirine	Total
Female	43	43	42	128
Male	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Dapivirine Gel 4759	Dapivirine Gel 4789	HEC-based Placebo Gel, 2.5g Containing no Dapivirine	Total
American Indian or Alaska Native	0	0	0	0
Asian	0	1	2	3
Native Hawaiian or Other Pacific Islander	10	9	4	23
Black or African American	16	16	15	47
White	17	14	18	49
More than one race	0	0	0	0
Unknown or Not Reported	0	3	3	6

Region of Enrollment
Region of Enrollment(participants)	Dapivirine Gel 4759	Dapivirine Gel 4789	HEC-based Placebo Gel, 2.5g Containing no Dapivirine	Total
United States	43	43	42	128

Married
Married(Participants)	Dapivirine Gel 4759	Dapivirine Gel 4789	HEC-based Placebo Gel, 2.5g Containing no Dapivirine	Total
Count of participants	9	7	12	28

In a relationship with one partner, not married
In a relationship with one partner, not married(Participants)	Dapivirine Gel 4759	Dapivirine Gel 4789	HEC-based Placebo Gel, 2.5g Containing no Dapivirine	Total
Count of participants	35	38	29	102

Cohabitating with main partner
Cohabitating with main partner(Participants)	Dapivirine Gel 4759	Dapivirine Gel 4789	HEC-based Placebo Gel, 2.5g Containing no Dapivirine	Total
Count of participants	9	16	12	37

In a relationship with multiple partners
In a relationship with multiple partners(Participants)	Dapivirine Gel 4759	Dapivirine Gel 4789	HEC-based Placebo Gel, 2.5g Containing no Dapivirine	Total
Count of participants	1	1	0	2

3 further baseline measures are reported on the registry.

Study locations

5 sites

University of Alabama at Birmingham, Alabama Microbicide Clinical Research Site (AMCRS)
Birmingham, Alabama 35294, United States
Harbor-UCLA Medical Center
Torrance, California 90502, United States
University of Illinois at Chicago
Chicago, Illinois 60612, United States
SNBL Clinical Pharmacology Center
Baltimore, Maryland 21201, United States
Albert Einstein College of Medicine
New York, New York 10461, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT00799058
Lead sponsor: International Partnership for Microbicides, Inc.
Responsible party: Sponsor
First posted: Nov 27, 2008
Start date: Jul 6, 2009
Primary completion: Jan 8, 2011
Completion: Jan 8, 2011
Results posted: Oct 25, 2022
Last update: Oct 25, 2022

Study contacts

Dr Annalene Nel

study chair · International Partnership for Microbicides

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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